Minimum Education/Experience Requirements:
- B.S./B.A. degree in Biology, Chemistry, bio-engineering or related science.
- Minimum of 8 years’ experience with the medical device and or diagnostics industry.
- Must have a minimum of 5 years regulatory experience in an IVD manufacturing environment with a proven track record of obtaining 510(k) or PMA approvals.
- Knowledge and experience with novel molecular in vitro diagnostic assays, software, and devices (and accessories to IVD’s) is a plus.
- Demonstrated knowledge in the design and process of regulatory requirements data collections and analysis.
- Working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of in vitro diagnostic assays and medical devices.
- Demonstrated ability to find solutions to achieve company goals in effective and efficient manner.
Preferable Skills and Attributes:
- Strong results orientation and effective change agent.
- Demonstrated problem-solving skill set in the regulatory and clinical environment with good business judgment.
- Ability to flourish in a fast-paced, multi-tasking and dynamic environment with a high level of ambiguity.
- Strong written and oral communication skills. The ability to present effectively to a wide spectrum of audiences, both internally and externally.
- Ability to build strong relationships across a wide spectrum of internal and external parties.
- Creative and innovative thinker.
- Ability to work with cross-functional teams to guide and obtain required regulatory documents.
- Entrepreneurial mindset; small company experience a plus.
Why Join Bio-Techne:
- We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
- We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
- We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
- We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
- We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.
Bio-Techne is an E-Verify Employer in the United States.